Label: ACETAMINOPHEN tablet

  • NDC Code(s): 84269-2522-1, 84269-2522-2
  • Packager: Wildman Business Group
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 20, 2024

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  • Active Ingredient (in each tablet)

    Acetaminophen

  • Purpose

    Pain reliever / fever reducer

  • Uses:

    For the temporary relief of minor aches and pains associated with:

    • headache
    • toothache
    • muscular aches
    • common cold
    • minor arthritis pain
    • menstrual cramps
    • For the reduction of fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use:

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • if you are allergic to acetaminophen or any of the inactive ingredients in this product

    Ask a doctor before use if you have:

    • Liver disease

    Ask a doctor or pharmacist before us if you are:

    • taking the blood thinning drug warfarin

    Stop use and ask a doctor if:

    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • new symptoms occur
    • redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children.

    In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions:

    Do not use more than directed

    Adults and children 12 years and over

    • take 2 tablets every 6 hours while symptoms persist or as directed by a doctor.
    • do not take more than 6 tablets in 24 hours, unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    Children under 12 years: Ask a doctor

  • Other information:

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
  • Inactive Ingredients

    Corn starch, unspecified povidone, sodium starch glycolate, stearic acid

  • Principal Display Panel – 250 Tablet Box Label

    2522

    Maximum Strength Pain Reliever

    ASPIRIN FREE

    COMPARE TO
    TYLENOL

    For Temporary
    Relief of Minor
    Aches and Pains

    250 tablets

    2 Per Packet

    The Provision
    First Aid
    Line™

    BY WILDMAN

    Principal Display Panel – 250 Tablet Box Label
  • INGREDIENTS AND APPEARANCE
    ACETAMINOPHEN 
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84269-2522
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen500 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorwhite (white) Score2 pieces
    ShapeROUND (ROUND) Size12mm
    FlavorImprint Code 44;148
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84269-2522-2125 in 1 BOX05/20/2024
    12 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:84269-2522-150 in 1 BOX05/20/2024
    22 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01305/20/2024
    Labeler - Wildman Business Group (016677338)
    Establishment
    NameAddressID/FEIBusiness Operations
    Future Pak, Ltd.087737672PACK(84269-2522)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837MANUFACTURE(84269-2522)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088MANUFACTURE(84269-2522)
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